SOUTH SAN FRANCISCO, Calif., Dec. 8, 2008 (GLOBE NEWSWIRE) -- Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced the successful completion of its Phase 1 clinical study in healthy volunteers of menadione topical lotion, its novel first-in-class compound in development for the prevention and/or treatment of the acneiform skin rash complication due to anti-cancer therapy with epidermal growth factor receptor (EGFR) inhibitors.
Study results showed that menadione was well tolerated at all doses tested. The open-label, modified dose-escalation study assessed the bioavailability, safety and tolerability of three concentrations (0.05%, 0.1% and 0.2%) of menadione and placebo administered to 12 healthy subjects with intact skin. Menadione or placebo was applied on the face, neck, upper chest and upper arms for 3.5 days every 7 days over a 28 day period. The study included skin biopsy specimens for analysis, patient tolerability questionnaires, and full pharmacokinetic sampling on all of the subjects at the various lotion strengths.
"We are encouraged by these study results that show study subjects experienced no appreciable systemic absorption of menadione at any concentration, which supports previously reported preclinical data that showed menadione does not interfere with the anti-cancer activity of EGFR inhibitors," said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. "We are very excited about the potential for this promising novel agent and are convinced that successful prevention and treatment of this skin toxicity is needed to maintain compliance of the anti-cancer therapy."
Acneiform rash is a common, painful, and treatment-limiting skin toxicity side effect of all EGFR inhibitors (e.g. Tarceva(r), Iressa(r), Erbitux(r), Vectibix(r)) with incidence rates as high as 90%. The skin rash can lead to reduced compliance and cause dose reductions, delays or discontinuation of EGFR inhibitor therapy in a significant portion of affected patients. Currently, there are no products or therapies FDA-approved to treat these skin toxicities.
Results from past preclinical studies demonstrated that menadione does not affect the anti-tumor effect of erlotinib (Tarceva(r)), an approved EGFR inhibitor. Other preclinical data showed menadione's ability to restore kinase activity in the presence of specific kinase inhibitors. These data indicate that treatment with menadione may result in restoration of normal cell turnover rates and prevent skin toxicities that result from inhibition of protein kinases associated with tumor growth signaling pathways, such as the tyrosine kinases EGFR, MEK, CDK and RAF.
In the completed Phase 1 study, adverse events considered at least possibly related to menadione that occurred most frequently included skin erythema and burning sensation that increased in frequency with concentration levels.
A Phase 1 study in patients receiving EGFR inhibitors for anti-cancer therapy in both rash emergent and rash pre-emergent settings is ongoing, and the Company expects to initiate a randomized Phase 2 trial during the first half of 2009.
About Menadione Topical Lotion
Menadione, a small organic molecule, is a novel, potential first-in-class compound that is designed to prevent or treat skin toxicity associated with epidermal growth factor receptor (EGFR) inhibitor anti-cancer therapy. EGFR inhibitors, or EGFRIs, are currently used to treat over 100,000 patients per year with a variety of cancers including non-small cell lung, pancreatic, colorectal, and head & neck cancer. Loss of EGFR signaling has been hypothesized as a mechanism of skin toxicity in patients receiving EGFRIs. The rash occurs primarily on the face, neck, and upper torso.
Menadione has been shown to activate the EGFR signaling pathway by blocking phosphatase activity in preclinical studies. In vitro studies suggest that topically-applied menadione may restore EGFR signaling at the dermal/epidermal junction, which could prove beneficial to patients who receive EGFRI cancer therapy. Hana Biosciences in-licensed menadione from the Albert Einstein College of Medicine in New York in October 2006. A Phase 1 clinical trial is ongoing in the U.S. and Canada.
About Hana Biosciences, Inc.
Hana Biosciences, Inc. (Nasdaq:HNAB) is a South San Francisco, CA-based biopharmaceutical company focused on acquiring, developing, and commercializing innovative products to strengthen the foundation of cancer care. The company is committed to creating value by building a best-in-class team, accelerating the development of lead product candidates, expanding its pipeline by being an alliance partner of choice, and nurturing a unique company culture. Further information on Hana Biosciences can be found at www.hanabiosciences.com.
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This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding the benefits to be derived from Hana's drug development programs, including the potential advantages of its topical menadione product candidate and its potential for use in the treatment of skin toxicities caused by the use of EGFR inhibitors, as well as the timing progress and anticipated results of the clinical development and regulatory processes concerning topical menadione. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Hana's development efforts relating to topical menadione or its other product candidates will be successful, that Hana will be able to obtain regulatory approval of any of its product candidates, and that the results of clinical trials will support Hana's claims or beliefs concerning the effectiveness of its product candidates. Additional risks that may affect such forward-looking statements include Hana's need to raise additional capital to fund its product development programs to completion, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2007 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.